FDA.reportPublic FDA data

NDC 62756-512-40 - Azithromycin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
62756-512
Requested NDC
62756-512-40
Package NDCs from labels
62756-512-40, 62756-512-44
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2020-04-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries LimitedSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2020-04-06Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62756-512-442020-06-16C16284748780-19d75b9d0-9103-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991
62756-512-442020-01-31C16284748780-19d75b9d0-9103-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-512-40Azithromycin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,519
62756-512-44Azithromycin10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-512AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20200715_6a22beb6-57e8-480d-97b5-44d9dbfabf93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-512-40EA - Each62756-512fdc4dd10-ec56-4729-82ac-a6ed341e03f712013-10-17
62756-512-44EA - Each62756-512000ea893-87f2-4991-baf3-85d0bb2174ba12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]8
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]8

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin monohydrateAZITHROMYCIN MONOHYDRATEGland Pharma Limited55051e03-b6dc-4bc6-87c1-e4fb84b61fa32026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: XF417D3PSL
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINEugia US LLC7b81436e-d14a-4353-a22d-253f45e2e5762026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Inc3b631aa1-2d46-40bc-a614-d698301ea4f92026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1668238
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.9e4fbd52-43e4-4d87-a136-f4d680a8d0c12026-03-12Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.